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Not yet recruiting NCT06607783

PRostate Cancer Enhanced Diagnosis by Calibration Technology

— Observational Prostate Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI.
Who it may be relevant to
Registry conditions: Prostate Cancers. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-Centre, Pivotal Stage, Study to Determine the Between MRI Scanner Reproducibility of Gold Standard Phantom Calibrated Acquisition Replicator (CARE) for Measurement of Apparent Diffusion Coefficients in the Prostate of Patients With MR Positive Lesions Destined for Biopsy

Overview

The CARE® Phantom system is a medical device system that is being developed has been designed to enable the quantitative measurement of the apparent diffusion coefficient (ADC) in the prostate of patients undergoing a multi-parametric MRI (mpMRI) scan to detect prostate cancer. The final device system will comprise three elements: a calibration mat containing phantoms and embedded monitoring software, a docking station to transfer data from the phantoms, and software as a medical device (SaMD) for calibrating the resulting mpMRI images. In this clinical trial, patients will undergo MRI scanning in different scanners using the GSP Phantoms to provide mpMRI images and phantom data for subsequent in silico analysis. The captured images and data will be used to further develop and calibrate the GSP prototype SaMD part of the medical device system, and to establish the degree of optimised reproducibility that can be achieved.

Interventions

  • Diagnostic test MRI
    Standard MRI using phantom.

Primary outcome measures

  • Determination of the Reproducibility of GSP CARE Reference Phantom on Different MRI Scanners [Time frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
Secondary outcome measures (5)
  • Assessment of Reproducibility Between MRI Scanners [Time frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
  • Observation of the Extent to Which Biopsy Can be Avoided when Using GSP CARE Phantom System [Time frame: From date of first participant enrolment until the date biopsy results of participants are received, assessed up to 6 months.]
  • Determination of Per-Lesion Diagnostic Accuracy of GSP CARE-Corrected ADC Measurements [Time frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
  • Determination of the Association Between GSP CARE Reference Phantom Corrected Lesion ADC Measurements and Tumour Gleason Grade [Time frame: From date of first participant enrolment until the date of the final ADC measurement analysis, assessed up to 18 months.]
  • Investigation of Device Usability [Time frame: From date of first participant enrolment until the date all radiographers and participants have completed a Usability Questionnaire, assessed up to 6 months.]

Eligibility criteria

Inclusion criteria

  • Men aged 18 years and older undergoing investigations for PCa.
  • Standard of Care MRI conducted.
  • One or more lesions with a Likert score of 3 or above identified on clinical reports.
  • Planned targeted biopsy within 6 months from the date of clinical care MRI.
  • Willing and able to provide written informed consent.

Exclusion criteria

  • Prostate specific antigen (PSA) level > 20ng/ml within 6 months
  • Previous diagnosis of prostate cancer
  • Ongoing hormone treatment within 3 months prior to MRI, excluding antiandrogens or 5-alpha reductase inhibitors
  • Contraindication to MRI scan

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United Kingdom · 1 center
  • University College Hospital — London

Identifiers

NCT: NCT06607783 · GSP001 · 10071751 · 340447

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗